Sunitinib Malate with or without Gemcitabine Hydrochloride in Treating Patients with Advanced Kidney Cancer that Cannot be Removed by Surgery
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 10-006075
NCT ID: NCT01164228
Sponsor Protocol Number: E1808
About this study
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Histologically confirmed* renal cell carcinoma
- Disease of any subtype allowed
- Disease must have sarcomatoid features NOTE: *Patients must have a paraffin-embedded tumor specimen from the kidney or metastatic site available for central review and confirmation of tumor histology
- No collecting duct or medullary carcinoma
- Measurable advanced disease that is not resectable by surgery
- Patients with resected or radiated brain metastases or those treated with stereotactic radiation therapy are eligible, provided they have been off steroids for at least 2 weeks
- ECOG performance status 0-2
- AGC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
- Serum creatinine clearance ≥ 30 mL/min
- SGOT and SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
- Total bilirubin ≤ 1.5 times ULN
- Baseline QTc interval < 500 msec on EKG
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception before and during study treatment
- Able to swallow pills
- No history of stroke within the past 6 months
- No clinically significant cardiovascular disease, defined as one of the following:
- Uncontrolled hypertension (BP > 150/100 mm Hg at the time of enrollment)
- Patients with hypertension and BP ≤ 150/100 mm Hg on stable antihypertensive regimen are eligible
- History of myocardial infarction or unstable angina within the past 24 weeks
- NYHA class II-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris
- Peripheral vascular disease ≥ grade II
- No ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by NCI CTCAE version 4
- No patients with a history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation > 3 beats in a row)
- No patients with ongoing atrial fibrillation
- No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication
- No serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment
- No known HIV
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study
PRIOR CONCURRENT THERAPY:
- No prior systemic therapy for metastatic disease
- Patients who were randomized to placebo on an adjuvant study are eligible
- More than 2 weeks since prior radiotherapy and recovered
- Previously irradiated lesions must not be the sole site of disease
- More than 2 weeks since prior and no concurrent ketoconazole, dexamethasone, dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
- Topical and inhaled steroids are allowed
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Manish Kohli, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office